The National Academies Press

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Pages 55-69

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From page 55... ... If a manufacturer wishes to add a new ingredient to infant formulas, it must either file a Food Additive Petition or declare it a Generally Recognized as Safe (GRAS) substance through a GRAS Notification process. Read the entire page →
From page 56... ... THE CURRENT U.S. REGULATORY SYSTEM In the United States infant formulas and ingredients added to infant formulas fall within the purview of the Office of Food Additive Safety and the Office of Nutritional Products, Labeling and Dietary Supplements of FDA's Center for Food Safety and Applied Nutrition. Read the entire page →
From page 57... ... , the subpart that defines the minimum quality factors for infant formulas. In these proposed regulations, FDA identifies two factors for which there is scientific basis to define them as quality factors, namely that the formula is "capable of supporting normal physical growth of infants" and "protein is of sufficient biological quality to meet the protein requirements of infants." FDA, in proposed rule Section 106.3(o) Read the entire page →
From page 58... ... . Routes to Add New Ingredients to Infant Formulas Infant formulas are regulated as food. Read the entire page →
From page 59... ... Limitations of the Current Process The GRAS Notification has become the route of choice for the introduction of new ingredients because it is scientifically rigorous, far more efficient, and equally or more transparent than the Food Additive Petition route. Still, the current process to assess the safety of ingredients new to infant formulas is complex and presents a number of limitations. Read the entire page →
From page 60... ... The committee's primary charge was to assess safety of new ingredients added to infant formulas under U.S. regulations, with possible international applications. Read the entire page →
From page 61... ... It is neither realistic nor desirable to design individual templates for each new ingredient; rather expert panels can refine the generic templates as needed. This approach is designed for a broad spectrum of ingredients and could be applied to new ingredients to be added to infant formulas regardless of the regulatory process used. Read the entire page →
From page 62... ... FIGURE 4-1 Proposed process for evaluating the safety of ingredients new to infant formulas algorithm. In-market assessment should be planned in conjunction with preclinical and clinical testing. Read the entire page →
From page 63... ... Element 3: Chemical or Biological Composition Many of the substances that can be considered for addition to infant formulas are natural components of human milk, but their source is plants or animals, or they are synthesized. The safety issues therefore often revolve around the purity of the ingredients, as most are components of complex mixtures and may contain other biologically active or possibly toxic substances. Read the entire page →
From page 64... ... for infant formulas must also be addressed in this area of the submission to ensure that no unusual safety concerns arise. Element 5: Intended Use in Foods The technical, functional, or nutritional rationale for adding the substance to the infant formula should be clearly stated. Read the entire page →
From page 65... ... Many of the ingredients being considered for addition to infant formulas are naturally occurring nutrients in human milk, yet simply because an ingredient is a component of human milk does not mean it is safe. The matrix effect, ratios of other components, and interactions with other ingredients must be taken into account before a safety conclusion can be drawn for an infant formula. Read the entire page →
From page 66... ... However in the proposed rule (Section 106.3(o) , subpart E, "Quality Factors for Infant Formulas") Read the entire page →
From page 67... ... As these examples show, any new ingredient considered for use in infant formulas must be considered in the context of its form, the matrix, and other ingredients with which it may interact. Specific procedures for assuring bioavailability will depend on the compound under consideration. Read the entire page →
From page 68... ... The committee strongly recommends that in selecting appropriate experts to analyze ingredients new to infant formulas, the expert panel should include a physician with experience in clinical assessment, preferably a pediatrician. The composition of the rest of the panel should be determined in consultation with the regulatory agency and will depend on the nature of the ingredient (e.g., if dealing with probiotics, a microbiologist and immunologist should be included on the panel) Read the entire page →
From page 69... ... Also, they do not provide either enough guidelines on the selection of an appropriate expert panel that may be used to show consensus or guidelines for in-market surveillance. There is an opportunity to address these limitations and standardize the elements of the safety assessment of ingredients new to infant formulas without being overly prescriptive. Read the entire page →

From page 55...

... If a manufacturer wishes to add a new ingredient to infant formulas, it must either file a Food Additive Petition or declare it a Generally Recognized as Safe (GRAS) substance through a GRAS Notification process.